The present invention relates to testing devices, and more particularly to devices for testing an elongated elastic sleeve or balloon.
A various assortment of catheters have been proposed in the past for use in patients. Many of such catheters, for example Foley catheters and endotracheal tubes, are constructed with an inflatable sleeve or balloon on a shaft to permit retention or sealing by the balloon in the patient's body. For example, Foley catheters are normally constructed having an elongated hollow shaft defining a drainage lumen, an inflatable sleeve secured on a distal end of the shaft, and a drainage eye adjacent the distal end of the shaft communicating with the drainage lumen. The catheter shaft is passed through the patient's urethra until the drainage eye and inflatable sleeve are located in the bladder, and a drainage tube is connected to a proximal end of the catheter shaft which is located outside the patient's body. The sleeve is inflated through a sidearm and inflation lumen of the catheter in order to expand the balloon in the patient's bladder, and retain the catheter in place. During catheterization, urine drains from the bladder through the drainage eye, the drainage lumen, and the drainage tube to a collection bag for retention therein.
The inflatable balloons or sleeves are normally constructed from a relatively thin elastic material, such as silicone, which may be formed by extrusion. It is not uncommon that the sleeves may contain imperfections, such as areas of weakness or pin holes, which deleteriously affect operation of the catheter balloon during use. For example, if the catheter balloon contains one or more pin holes, the balloon may deflate in the patient's body, thus rendering the catheter balloon useless. In some instances, the defective balloon may be undetected by the physician, and may result in possible harm to the patient. Thus, it is necessary to assure that the catheter balloon is in an acceptable condition before supplying the catheter to the physician.
In the past, catheter balloons have been tested pursuant to manufacture by individually inflating each of the balloons after securement onto the catheter shaft. It will be apparent that this procedure is both time consuming and tedious, and necessarily adds to the manufacturing cost of the catheter. Moreover, such tests merely ascertain that the balloon may be inflated, and may not reveal more serious defects in the balloon which are not apparent during inflation. For example, the balloon may have an area of weakness which may rupture during use, particularly when stresses are applied to the inflated balloon, or the balloon may have one or more relatively small pin holes which leak slowly during an extended period of time. Further, even if a defect in the balloon is discovered by this procedure, the balloon has been previously secured onto the catheter shaft, and the entire catheter must be discarded due to the faulty balloon, thus unnecessarily resulting in waste and additional cost to the manufacturing procedures.